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ISRCTN
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ISRCTN95504420
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DOI
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10.1186/ISRCTN95504420
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A study on side effects such as nausea and vomitus after medication to prevent excessive bleeding after a caesarean section
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Scientific title
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OBGYN-1: A randomized controlled trial on nausea, vomitus and blood pressure changes comparing carbetocine versus oxytocine in the prevention of hemorrhage after caesarean section
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Acronym
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NAVOCASY
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Serial number at source
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OBGYN-1
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Study hypothesis
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Single shot intraveneous carbetocin is accompanied with more nausea and vomitus as compared to intravenous oxytocin.
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Lay summary
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Background and study aims
At the end of a cesarean section in Belgium, in general some medication is given to the mother to prevent excessive bleeding. The two products used most frequently are called carbetocin and oxytocin and work well. No difference has been demonstrated as far as the effect on prevention of bleeding is concerned. A major side effect of this kind of medication is nausea and vomitus and a lowering of blood pressure resulting in dizziness. The aim of the present study is to compare nausea, vomiting and changes in blood pressure between carbetocin and oxytocin.
Who can participate?
Any pregnant woman for whom a caesarean section is planned in a term ( full grown) pregnancy without any other complication can participate.
What does the study involve?
Participants are randomly allocated to one of two groups:
All women will receive an intravenous medication to prevent bleeding and no one (participant, operating or treating team) will not know whether the medication used is carbetocin or oxytocin.
What are the possible benefits and risks of participating?
There is no difference with routine management during which both medications are used. The results of this study will help future patients to receive the product with the fewest side effects.
Where is the study run from?
The study will be run in the Obstetrics Ward at Antwerp University Hospital UZA, Belgium.
When is the study starting and how long is it expected to run for?
The study will be running for one year and will start in March 2013.
Who is funding the study?
This study is not funded by any pharmaceutical company, all costs are taken care of by the local ‘Fund for perinatal Medicine’ of the Department of Obstetrics at Antwerp University Hospital
Who is the main contact?
Prof Dr Yves Jacquemyn
Yves.jacquemyn@uza.be
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Ethics approval
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Ethics Committee Ethisch Comité Universitair Zieknhusi Antwerpen, 21st February 2011, ref: B300201110299
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Study design
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Prospective randomized controlled trial
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Countries of recruitment
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Belgium
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Disease/condition/study domain
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Pregnancy and delivery
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Participants - inclusion criteria
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Term uncomplicated pregnant women who undergo a planned cesarean section.
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Participants - exclusion criteria
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1. Unplanned caesarean section
2. Complications including: hypertension, preterm labour, any gatsrointestinal or cardiovascular disease necessitating treatment
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Anticipated start date
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15/02/2013
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Anticipated end date
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15/02/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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60
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Interventions
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Standard intravenous carbetocin vs standard intravenous oxytocin
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Primary outcome measure(s)
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From the moment the participant enters the operating theatre until one hour later, blood pressure and heart frequence are carefully registered every 5 minutes or more as during routine monitoring of surgery. Nausea and vomitus are evaluated before surgery (just before incision), during surgery: before giving the intravenous medication and after 5, 10 and 15 minutes based on the standardized scale:
0: no nausea, no vomitus
1: mild nausea, no vomiting
2: nausea but with retching, no vomiting
3: nausea and vomiting
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Secondary outcome measure(s)
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Any other complaint
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Sources of funding
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Department of Obstetrics, Antwerp University Hospital (Belgium)
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Trial website
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Publications
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Contact name
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Prof
Yves
Jacquemyn
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Address
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Wilrijkstraat 10
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City/town
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Edegem
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Zip/Postcode
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2650
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Country
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Belgium
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Email
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yves.jacquemyn@uza.be
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Sponsor
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Antwerp University Hospital (Belgium)
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Address
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Department of Obstetrics
Wilrijkstraat 10
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City/town
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Edegem
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Zip/Postcode
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2650
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Country
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Belgium
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Email
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yves.jacquemyn@uza.be
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Date applied
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03/02/2013
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Last edited
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28/02/2013
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Date ISRCTN assigned
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28/02/2013
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